A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer

NCT06363552 | Not Yet Recruiting Phase 2

• 1 other identifier: WETARI
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate

  12 months

• Incidence and Severity of Dose Limiting Toxicities (DLTs)

  12 months

Study Arms (3)

SC0191

EXPERIMENTAL

Drug: SC0191

SC0191 + Bevacizumab

EXPERIMENTAL

Drug: SC0191 + Bevacizumab

SC0191 + 5-FU/LV

EXPERIMENTAL

Drug: SC0191 + 5-FU/LV

Interventions

SC0191 DRUG

The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle.

SC0191

SC0191 + Bevacizumab DRUG

1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Bevacizumab injection is administered intravenously at a dose of 5mg/kg on day 1 and day 15 of each treatment cycle.

SC0191 + Bevacizumab

SC0191 + 5-FU/LV DRUG

1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Calcium folinate 400mg/m2 intravenous infusion (over 2 hours or more), on the first day, followed by 5-fluorouracil 400mg/m2 intravenous bolus injection, then continuous intravenous infusion of 1200mg/m2/day for 2 days.

SC0191 + 5-FU/LV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily participate in the clinical study and sign an informed consent form;
• Male or female subjects aged ≥18 years;
• Subjects diagnosed with stage IV colorectal cancer confirmed by histology or cytology and not suitable for curative surgical treatment;
• Subjects who have previously received fluoropyrimidine-based chemotherapy, oxaliplatin, and irinotecan with or without anti-EGFR or anti-VEGF targeted therapy, and experienced disease progression or intolerance to the most recent treatment regimen; the number of prior lines of systemic antitumor therapy for advanced colorectal cancer does not exceed 2 lines;
• ECOG performance status of 0 to 1;
• Expected survival of ≥3 months;
• At least one measurable lesion according to RECIST 1.1 criteria, defined as a lesion with a longest diameter ≥10 mm on CT scan or MRI (excluding lymph nodes) or a short diameter ≥15 mm for lymph nodes. Lesions located in previously irradiated or otherwise locally treated areas are generally not considered measurable unless there is documented disease progression;
• Adequate organ function and bone marrow hematopoietic function;
• Fertile subjects (both male and female) must agree to use a reliable method of contraception (hormonal or barrier method, or abstinence) with their partners for at least 6 months from the time of signing the informed consent form until the last dose of the study drug; female subjects of childbearing potential must have a negative pregnancy test within 14 days before the first use of the investigational drug.

You may not qualify if:

• Subjects known to be MSI-H who have not received immunotherapy;
• Subjects with radiological evidence of tumor invasion or encasement of major vessels (Cohort A);
• Subjects with uncontrollable pleural effusion, ascites, or pericardial effusion at screening;
• Subjects with a history of other malignant tumors within 5 years prior to study drug initiation, except for early-stage tumors cured by curative treatment, such as basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, superficial bladder cancer, localized prostate cancer, etc.;
• Subjects with significant cardiovascular diseases, including NYHA class II-IV heart failure, congestive heart failure, second-degree or higher atrioventricular block, myocardial infarction within the past 6 months, unstable arrhythmias or angina, significant QT interval prolongation (baseline-corrected QTc interval \>470 milliseconds on ECG), stroke within the past 6 months, or PTCA (percutaneous transluminal coronary angioplasty) or CABG (coronary artery bypass grafting) within the past 6 months;
• Subjects with poorly controlled hypertension;
• Subjects with viral infectious diseases at screening meeting the following criteria:
• HIV seropositivity;
• Hepatitis B: HBsAg positivity with HBV-DNA quantification above the upper limit of normal;
• Hepatitis C: HCV antibody positivity with HCV-RNA quantification above the upper limit of normal;
• Subjects with active infections requiring systemic antimicrobial therapy as judged by the investigator, deemed unsuitable for participation in this study;
• Subjects who have undergone allogeneic tissue/organ transplantation;
• Subjects with malabsorption syndrome or other gastrointestinal abnormalities that may significantly affect oral drug absorption (such as ulcerative lesions, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection, etc.);
• Subjects with hereditary bleeding or coagulation disorders, or a history of severe non-traumatic bleeding, or a history of ineffective platelet transfusion (within the past 1 year before initial study drug administration), or any disease that significantly increases the risk of bleeding;
• Subjects with a history of any of the following during treatment with Bevacizumab-based regimens (or biosimilars): venous or arterial thromboembolic events, gastrointestinal perforation, grade 4 hypertension, grade 3 proteinuria, or grade 3 or higher bleeding events (Cohort A).

Sponsors & Collaborators

• Tianshu Liu: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Tianshu Liu, MD, PhD

CONTACT

+86 136 8197 3996; tianshu.liu@zs-hospital.sh.cn

Qing Liu, PhD

CONTACT

+86 136 4174 9704; liu.qing@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Oncology Department

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)